A Phase I/II Study of NEXI-002 Cellular Immunotherapy in People with Recurrent or Persistent Multiple Myeloma

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Full Title

A Phase 1/2 Study to Evaluate the Safety and Tolerability of Adoptively Transferred Autologous T cells in Patients with Relapsed Refractory Multiple Myeloma (CP-NEXI-002-01)

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational immunotherapy NEXI-002 in patients with multiple myeloma that has come back or continued to grow despite prior treatment. NEXI-002 is made in a laboratory using white bloods cells (T cells) that are able to recognize and destroy cancer cells.

The T cells are collected from the patient and grown to produce hundreds of millions of similar T cells that may be able to identify and kill multiple myeloma cells. These cells are returned to the patient intravenously (by vein). Patients will receive the chemotherapy drugs fludarabine and cyclophosphamide first to prepare them to receive NEXI-002.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have recurrent or persistent multiple myeloma after at least three prior regimens of standard treatment.
  • Patients’ cancers must have a protein called HLA-A*0201.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. David J. Chung at 646-608-3770.

Protocol

20-570

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators